Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)

About the role

The successful candidate will be a core member of the Regulatory team, working in close collaboration with the SVP, Head of Regulatory Affairs and other cross-functional colleagues. This role will develop and execute the global regulatory strategy in collaboration with key internal stakeholders, as well as implement that strategy tactically, guiding and executing compliant, high-quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities.

This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines and ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).

Responsibilities

• Develop a comprehensive regulatory strategy that accounts for worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions.
• Identify potential risks and mitigation strategies associated with proposed strategies.
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval.
• Support communication with global Health Authorities (HA), such as FDA and EMA, including planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develop and execute, or oversee, global regulatory strategy for long-term planning, including accommodating expedited development needs.
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for development challenges.
• Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence.
• Ensure adherence to current regulations associated with regulatory activities.
• Work strategically with all regulatory functions to develop detailed, actionable submission plans, track major submission deliverables, and ensure consistent management of submission documents, health authority communications, and other regulatory information supporting Nurix’s investigational and marketing applications.
• Define requirements for, implement, and support future systems and tools for document management, submission content planning, and regulatory information management.
• Track the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies.
• Develop and maintain submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs.
• Participate in cross-functional process initiatives impacting regulatory submission processes and systems.
• Manage consultants and contractors as needed.

Requirements

• Bachelor's degree in life sciences or related scientific discipline; advanced degree preferred.
• Minimum of 12 years in Regulatory Affairs strategy with significant experience in the oncology (solid tumors) therapeutic area.
• Strong knowledge of drug development, FDA, EMA, and ICH guidelines and regulations.
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA and EMA.
• Proven track record of supporting Regulatory Affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications.
• Strong project management and critical thinking skills.
• Experience applying project management techniques and tools (e.g., Veeva RIM, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions.
• Excellent organizational and communication skills, both written and verbal.
• Ability to work independently as well as part of a team environment.
• Positive attitude, energetic, and proactive.
• Proven ability to manage multiple projects, identify, and resolve regulatory issues.
• Strong interpersonal skills and the ability to effectively work with others.

Pay

Director: $232K - $274K

Senior Director: $279K - $331K

Location

Brisbane, CA (Onsite role)

Nurix Culture and Values

• Strong team orientation; highly collaborative.
• Solutions and results-oriented focus.
• Hands-on approach; resourceful and open to diverse points of view.